Cidofovir

In the clinical treatment of refractory viral diseases such as cytomegalovirus (CMV) infection, cidofovir is a representative acyclic nucleotide antiviral drug. Its mechanism of action is to block the synthesis and replication of viral DNA by inhibiting the activity of viral DNA polymerase, and it has strong inhibitory activity against a variety of DNA viruses such as CMV, herpes simplex virus and poxvirus. Clinically, it is mainly used to treat CMV retinitis in patients with immunodeficiency (including AIDS patients), and is also used off-label for the treatment of special viral infections such as variola virus infection and BK virus-associated nephropathy. It is an important variety in the reserve catalogue of antiviral therapy.At present, the global market size of cidofovir is approximately US$230 million. Driven by the expansion of the immunodeficient population and the growing demand for prevention and control of special viral infections, the compound annual growth rate in the past three years has remained at 4.7%. In terms of competitive landscape, the original research product still accounts for more than 60% of the share in the mainstream markets of Europe and the United States, and Indian generic versions mainly flow to the markets of less developed countries. The domestic market is still dominated by imported preparations at present, and a number of pharmaceutical companies have arranged for the research and development of generic drugs. With the reduction of generic threshold after patent expiration, the space for domestic substitution in the future is considerable.The original research enterprise of cidofovir is Gilead Sciences, and the original research trade name is Vistide. Its core compound patent in the United States expired in 2003, and the compound patent in China also expired in 2005. The main dosage form approved by the original research is injection, with the specification of 5ml:375mg. The original research injection has been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by NMPA, and is also a reference preparation listed by FDA. As of the time of retrieval, there is no approved cidofovir A status registration number on the domestic CDE API registration platform. The imported original research injection has been approved for marketing in China, and no domestic cidofovir preparation has been approved yet. (Data as of June 2025, please refer to the official CDE website for the latest information)CATO provides a full set of cidofovir impurity reference standards, which can fully cover the reference standard requirements in each stage of API research and development, quality research, and registration declaration. Most of the products can be supplied from stock, and in-stock products ordered before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, which can effectively help pharmaceutical companies shorten the R&D cycle and reduce the cost of quality research.

目前全球西多福韦市场规模约为2.3亿美元，受免疫缺陷人群规模扩大、特殊病毒感染防控需求增长驱动，近三年年均复合增长率保持在4.7%。竞争格局方面，原研产品仍占据欧美主流市场60%以上的份额，印度仿制版本主要流向不发达国家市场；国内市场目前仍以进口制剂供应为主，已有多家药企布局仿制药研发，随着专利到期后仿制门槛降低，未来国产替代空间较为可观。

西多福韦原研企业为吉利德科学，原研商品名为Vistide。其美国核心化合物专利已于2003年到期，中国化合物专利也于2005年届满。原研获批的主要剂型为注射剂，规格为5ml:375mg，原研注射剂已被列入NMPA发布的《化学药品参比制剂目录》，同时也是FDA收录的参比制剂。截至检索时点，国内CDE原料药登记平台暂无获批的西多福韦A状态登记号，国内已有进口原研注射剂批准上市，暂未有国产西多福韦制剂获批。（数据截至2025年6月，最新请以CDE官网为准）

CATO/佳途科技提供西多福韦全套杂质标准品，可充分覆盖原料药研发、质量研究、注册申报各阶段的对照品需求，大部分产品可实现现货供应，现货产品16:00前下单即可当天发货，所有标准品均符合中国药典、FDA等多法规体系合规要求，能有效助力药企缩短研发周期，降低质量研究成本。